Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/10—Location thereof with respect to the patient's body
  • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
  • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
  • A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/20—Type thereof
  • A61M60/205—Non-positive displacement blood pumps
  • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
  • A61M60/226—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly radial components
  • A61M60/232—Centrifugal pumps
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/40—Details relating to driving
  • A61M60/403—Details relating to driving for non-positive displacement blood pumps
  • A61M60/422—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/80—Constructional details other than related to driving
  • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
  • A61M60/818—Bearings
  • A61M60/82—Magnetic bearings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/80—Constructional details other than related to driving
  • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
  • A61M60/818—Bearings
  • A61M60/82—Magnetic bearings
  • A61M60/822—Magnetic bearings specially adapted for being actively controlled
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/80—Constructional details other than related to driving
  • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
  • A61M60/833—Occluders for preventing backflow
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/80—Constructional details other than related to driving
  • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
  • A61M60/857—Implantable blood tubes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
  • A61M60/80—Constructional details other than related to driving
  • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
  • A61M60/861—Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body

Definitions

• TITLE Unloading blood pump system and its blood pump.
• the technical field of the invention generally relates to the field of blood pumps. More specifically, the invention relates to a blood pump, suitable for implantation in humans and for unloading a cardiac chamber to reduce the risk of heart failure (HF) with preserved ejection fraction (ICFEP).
• HF heart failure
• IFEP preserved ejection fraction
• the present invention also relates to a blood pump system for unloading a zone of a heart for the reduction of heart failure (HF) with preserved ejection fraction (ICFEP) and its blood pump.
• HF heart failure
• IFEP preserved ejection fraction
• HF heart failure disease
• IFEP preserved ejection fraction
• ICFER heart failure with preserved ejection fraction
• LVEF left ventricular ejection fraction
• An ejection fraction EF ⁇ 40 - 50% affirms the CI with reduced or diminished ejection fraction (ICFER). Otherwise, in case of EF > 40 - 50%, one evokes heart failure with preserved ejection fraction (ICFEP).
• Specific criteria of relaxation disorder and diastolic dysfunction can confirm the diagnosis.
• ventricular assist devices for the most important cases of fractional heart failure reduction. reduced or diminished ejection (ICFER).
• the ventricular assist devices comprise a pump making it possible to assist the heart by pumping blood at a rate according to the needs of the heart, the useful nominal rate of which is approximately for an adult 51/min at rest and during exercise can rise to 35-40 L/min in athletes. These pumps make it possible to assist the heart between 2L and 10L/min when this does not allow sufficient cardiac output. These pumps are quite bulky due to the power required to pump blood flow from the left ventricle to the aorta.
• Rotary blood pumps can be centrifugal or axial.
• a centrifugal blood pump blood enters the pump along its axis of rotation and exits the pump perpendicular to the axis of rotation.
• an axial blood pump blood enters the pump along its axis of rotation and exits the pump along the axis of rotation.
• Axial pumps are less bulky than iso-flow centrifugal pumps, but the centrifugal pump allows a higher flow rate at iso speed of rotation, thereby reducing the problems of thrombosis and hemolysis.
• the invention offers a solution to the problems mentioned above, by making it possible to reduce the atrio-pulmonary pressure without increasing the pulmonary flow compared to the creation of an inter-atrial.
• the resonance of ICFEP is directly related to the increase in pressure and the passive dilation of the pulmonary vessels. Any increase in pressure leads to an increase in the diameter of the pulmonary artery leading to a reduction in endothelial shearing causing adverse effects on endothelial functions. If the pressure stimulus persists, functional and structural remodeling takes place in the pulmonary arterial circulation resulting in pulmonary arterial hypertension and thus right heart failure. Thus by decreasing the pulmonary capillary pressure, the symptoms of heart failure with preserved ejection fraction (ICFEP) are reduced.
• ICFEP preserved ejection fraction
• an offloading blood pump system comprising: an aspiration cannula including an aspiration inlet configured to connect to an atrium or ventricle and an outlet end, an aspiration cannula flow reinjection comprising an inlet end and a reflux end connected to the aorta or an artery downstream of the aorta, in particular a subclavian artery, for example on the left, an unloading blood pump comprising: a pump for pumping blood when activated, an inlet connected to the outlet end of the suction cannula, for drawing blood from the suction cannula into the body of the pumping chamber and an outlet port connected to the inlet end of the flow reinjector cannula for expelling blood from the pumping chamber to a reinjector cannula, the pump being configured to as a function of its supply enable continuous flow con nominal stant situated between 0.05L/min and 0.5L/min in order to reduce a pulmonary capillary pressure and/or of
• the pump can pump blood to reduce the pressure of the left atrium also called the left atrium and/or the left ventricle by discharging through the pump blood circulating in the left atrium. , that is, part of the blood from the pulmonary veins goes to an artery without passing through the aortic valve.
• this collected blood passes from the left atrium to an artery downstream of the aorta without passing through the mitral valve, the left ventricle and the aortic valve.
• the low constant continuous flow allows blood to be discharged into the left side of the heart to decrease atriopulmonary pressure without increasing cardiac output as much as an assist pump.
• the pressure in the left atrium at rest in the ICFEP is between 20 and 30 mmHg, so when using the pump, it is adjusted to a rotational speed to obtain the desired (calculated) constant flow to reduce the patient's atriopulmonary pressure as needed.
• Such a discharge of blood in the left atrium or left ventricle makes it possible to decrease capillary pressure or in the left ventricle or left atrium.
• the clinical and ultrasound parameters then make it possible to know whether the continuous flow rate of the pump is sufficient to unload the heart sufficiently or excessively.
• the pump is rotated to discharge 0.05l/m for example at 2000 revolutions per minute, if the pressure in the heart is still too high (end diastolic pressure of the left ventricle), the rotation speed can be increased and thus the flow rate until the desired pressure is obtained, and vice versa.
• a pump is much less powerful than the assistance pumps and is therefore much less bulky and also requires less energy.
• the lower the flow rate of the pump the less powerful it is and the smaller the size as well as its consumption of energy, for example electricity. This allows, for example, in the case of electrical energy consumption, to be able to have a battery storage means or even to have a power cable (pneumatic or electric) of smaller size than that of the pumps of the prior art.
• the section of the inlet and outlet of the pump part connected to the cannulas can be smaller due to the lower flow rate than that of the assistance pumps.
• Such a pump thus makes it possible not to be oversized compared to that of the prior art sized to produce a flow rate of at least 2L/min.
• the clip makes it possible to ligate in order to avoid any competition of flow with the heart and to allow the discharge of the heart. Indeed, the clip, for example, ligates 90% of the artery upstream of the outlet orifice to avoid a risk of thrombosis and thromboembolic events.
• the unloading blood pump system may have one or more additional characteristics among the following, considered individually or in all combinations technically possible:
• the pump comprises a casing adapted to be incorporated into a human body.
• such a pump can have a size of approximately a pacemaker, which reduces the inconvenience of a patient but also greatly reduces the size of the energy battery (pneumatic or electric) which can be more easily portable.
• the energy consumption electrical to pneumatic
• the section of the power supply cables electrical to pneumatic
• the rotor is configured to rotate at a continuous speed between 2000 and 5000 revolutions per minute and in particular between 2000 revolutions per minute for a flow rate of 0.05L/min and 5000 revolutions per minute for a flow rate of 0.5 L/min.
• a pump makes it possible to meet the needs of a majority of patients and makes it possible to produce the pump on a large scale. Thus, such a pump makes it possible to be even smaller.
• the pump comprises a maximum flow rate of 0.7 l/min.
• the unloading blood pump comprises a casing adapted to be incorporated in a human body, at least one stator integral with the casing comprising winding coils, a rotor mounted centered and movable in rotation by relative to the stator, a turbine turned by the rotor, a power supply connector electrically connected to the winding coils, the pumping chamber body being mounted in the casing housing the turbine, in which the inlet port allows aspirate blood from the suction cannula towards the body of the pumping chamber when the rotor turns the turbine and the outlet orifice makes it possible to expel blood from the pumping chamber towards the reinjection cannula.
• the pump is a centrifugal pump. This reduces hemolysis compared to an axial pump and reduces pump wear. In addition, axial pumps cause more thromboembolic events than centrifugal pumps.
• the rotor is a magnet rotor and the stator comprises an electrically powered winding.
• a rotor makes it possible to avoid having bulky and non-permanent brushes unlike magnets.
• the pump part is directly coupled to the rotor shaft.
• Directly coupled means that one revolution of the rotor is equal to one revolution of the pump part.
• the rotor forms a centrifugal pump impeller rotor housed in the body of the pumping chamber to pump blood at a rate of between 0.05 L/min and 0.5 L/min.
• the rotor turbine also called paddle wheel or impeller allows when it is rotating to suck and eject the flow of liquid in this case the blood in the body of the pump chamber which ejects this liquid through the outlet orifice.
• the rotor comprises: an axial orifice facing the inlet orifice located axially with respect to the axis of rotation of the rotor, magnets regularly distributed angularly around the axial orifice , notches each located between two magnets, each notch extending longitudinally by emerging from the inlet orifice at an outer periphery of the rotor and having an inclined ramp increasing the axial depth of the notch of the inlet orifice towards the outer periphery of the rotor, and in that each notch is open to the volume of the pumping chamber surrounding at least the notches of the rotor, and the rotor forming the rotating wheel located in the body of the pumping chamber is adapted to pressurizing the blood entering through the inlet axially and exiting it radially through the outlet through the volute.
• the pump includes a drive portion includes multiple magnetic motor stators and the rotor has multiple magnetic regions and is levitated axially and radially rotated by magnetic forces created by passive and active sources of magnetic flux acting on the rotor and one or more hydrodynamic thrust bearings provided on an upper surface of the wheel.
• the pump is a centrifugal levitation pump comprising a passive bearing with permanent magnets.
• the permanent magnet passive bearing comprises an axis-centered stack of magnets attached to the stator, stacked with alternating North South polarity and another stack of magnets attached to the rotor, surrounding the first stack of the stator to together exert a first axial force on the rotor.
• the pump comprises a battery electrically connected to the drive part. This makes it possible to operate without being permanently connected to an external power supply.
• the pump comprises a wireless charger, of the inductive type to charge the battery.
• a wireless charger of the inductive type to charge the battery.
• the pump avoids having power cables crossing the skin connected to a battery or charger.
• the pump comprises a control unit for controlling the supply to the driving part, in particular the stator.
• Such a pump makes it possible to avoid the problems of infections of the outlets of the power cable passing through the skin. Due to its low power consumption, such a pump avoids power cables crossing the skin that can lead to infections.
• the pump comprises a power cable connected to the connector, the cable being adapted to pass through an intercostal space, or through the abdominal wall, or retroauricular.
• the pump is magnetic and hydromechanical suspension.
• the pump housing has a size between 3 cm and 5 cm in diameter and between 1.5 cm and 4 cm in axial length, in particular 4 cm (diameter) x 3 cm (axial length).
• a pump size allows it to be implanted in the subclavicular region, for example on or under the pectoralis major muscle, in a pocket made in the subclavicular region.
• a pump will have a casing having an external diameter smaller than a centrifugal rotor diameter of a power-assisted pump which is approximately 65mm with an axial length of 45mm. In other words, such an unloading pump is much smaller than that of an assistance pump.
• the pump is a positive displacement pump, also called positive displacement pump, in which for example the turbine comprises two lobes for moving blood.
• the volumetric pump is a pneumatic or electric pump.
• the suction cannula comprises at least one part in polyethylene terephthalate in textile form (PET) or in polytetrafluoroethylene in microporous form (ePTFE) comprising the proximal orifice or else in another biocompatible material.
• PET polyethylene terephthalate in textile form
• ePTFE polytetrafluoroethylene in microporous form
• the suction cannula comprises a treated biocompatible titanium part comprising the suction tip and the ePTFE PET part connects the titanium part to the inlet port. of the pump part.
• the reinjection cannula comprises at least one part made of PET or ePTFE or in another biocompatible material comprising the proximal orifice.
• the reinjection cannula comprises a treated biocompatible titanium part comprising the inlet end and the PTFE part connects the titanium part to the outlet orifice of the pump part.
• the reinjection cannula and the suction cannula have a diameter of between 5 mm and 10 mm.
• the clip extends from a part of the reinjection cannula close to the outlet orifice. This allows during the operation to have the clip close to the cannula and thus help the surgeon during the operation.
• the pump is an electrically powered pump and the system comprises a control and power supply device comprising a battery and a control unit for controlling the electrical power supply of the pump by the pump. a predefined continuous rate.
• the control unit is intended to control the pump continuously (without interruption). This avoids the risk of thrombosis and thromboembolic events.
• the system may include a signaling device, for example sound or light, controlled by the control unit according to the battery voltage measured by the control unit, to warn the user .
• the system comprises a power cable connected to a connector of the pump and to the control unit, the power cable being configured to pass through the skin of a human body.
• the housing comprises a casing which extends in material with a portion of the reinjection cannula and of the suction cannula.
• Another aspect of the invention relates to a method of implanting an offloading blood pump system (for example that according to the aspect of the invention described above with or without the various characteristics of the embodiments mentioned above), the method comprising:
• a step of clamping in two zones of the subclavian artery a step of anastomosis of the reinjection cannula by inserting its reflux end between the two clamps and downstream of the clipping, a step of removing the clamp from the artery subclavian, a step for calculating the flow rate to be discharged from a left atrium to avoid an ICFEP, a step for adjusting the control unit of the pump according to the calculated flow rate, a step for starting the pump by the control unit.
• Another aspect of the invention relates to a method of implanting an offloading blood pump system (for example that according to the aspect of the invention described above with or without the different characteristics of the embodiments mentioned above), the method comprising: a step of inserting the suction end of the suction cannula into the left atrium, by inserting the aspiration cannula by endovascular route firstly through the internal jugular vein then the right atrium and finally through the inter atrial septum to enter the left atrium, a step for debubbling the discharge pump, a ligation step, for example by clipping, of the subclavian artery to ligate between 85 and 100% of the artery.
• a step of clamping in two zones of the subclavian artery a step of anastomosis of the reinjection cannula by inserting its reflux end between the two clamps and downstream of the clipping, a step of removing the clamp from the artery subclavian, a step for calculating the flow rate to be discharged from a left atrium to avoid an ICFEP, a step for adjusting the control unit of the pump according to the calculated flow rate, a step for starting the pump by the control unit.
• an unloading blood pump comprising: a casing adapted to be incorporated in a human body, at least one stator secured to the casing comprising winding coils, a rotor mounted centered and movable in rotation relative to the stator, a turbine turned by the rotor, an electrical power connector electrically connected to the winding coils, a pumping chamber body mounted in the casing housing the turbine, an inlet port for drawing blood from a suction cannula to the body of the pumping chamber as the rotor rotates the impeller and an outlet port for expelling blood from the pumping chamber to a reinfusion cannula, characterized in that the pump is configured to, depending on its power supply, allow a nominal constant continuous flow rate situated between 0.05 L/min and 0.5 L/min in order to reduce pulmonary capillary pressure, and/or of the left atrium and/or of the left ventricle.
• the pump may include the features described in the examples of the embodiment of the pump system according to the aspect of the invention described above comprising such a blood pump.
• an unloading blood pump comprising: a casing adapted to be incorporated into a human body, a membrane, a pneumatic supply connector for moving the membrane, a chamber body pumping chamber mounted in the housing housing the membrane, an inlet port for drawing blood from a suction cannula into the body of the pumping chamber as the rotor rotates the impeller, and an outlet port for expelling blood from pumping chamber to a reinjection cannula,
• the pump is configured to, depending on its power supply, allow a nominal constant continuous flow rate between 0.05 L/min and 0.5 L/min in order to reduce pulmonary capillary pressure, and/or the atrium left and/or left ventricle.
• FIG. 1 represents a block diagram of an unloading blood pump system according to the invention implanted to reduce capillary pressure according to a first use
• FIG. 2 represents according to a block diagram of a blood pump for unloading the system according to a first mode of the invention.
• FIG. 3 shows a block diagram of an offloading blood pump system according to the invention implanted to reduce capillary pressure according to a second use
• Figure 1 shows a block diagram of a block diagram of an unloading blood pump system according to the invention implanted to decrease a capillary pressure according to a first use.
• the patient comprises a heart 1 comprising a left part A and a right part B.
• Blood vessels 2A supply blood to the left part of the heart which sucks it in and pushes the blood back into an aorta 3A.
• the left part A comprises a left atrium 10A, a left ventricle 11A, a left atrioventricular valve also called mitral valve 12A between the left atrium 10A and the left ventricle 11A, and an aortic valve 13A between the left ventricle 11A and the aorta 3A.
• the aorta 3A distributes blood to various arteries including the left subclavian artery 30A.
• the right part B also includes a right atrium 10B, a right ventricle 11B, a right atrioventricular valve also called tricuspid valve 12B between the right atrium 10B and the right ventricle 11B.
• Arrows represent the circulation of blood 3A in the heart 1 from the blood vessels 2A passing first through the left atrium 10A, then through the atrioventricular valve 12A into the left ventricle 11A and finally into the aorta 3A through the aortic valve 13A.
• the offloading blood pump system 4 is mounted in this first use to offload blood from the left atrium 10A to the left subclavian artery 30A.
• the unloading blood pump system 4 comprises an aspiration cannula 41, a reinjection cannula 43 and an unloading blood pump 40 and in this example of this embodiment a ligature member in this case a 430 clip that can be replaced by a lasso.
• the blood pump 40 includes an inlet port 401, connected to an outlet end 412 (referenced in Figure 2) of the suction cannula 41 and an outlet port 403 connected to an inlet end 432 (referenced in Figure 2) of the reinjection cannula 43.
• the suction cannula 41 comprises a suction end 411, opposite the outlet end 412, which in this example is located in the left atrium 11A and the reinjection cannula 43 includes a reflux end 433 opposite the inlet end 434 located in this example in the left subclavian artery.
• Clip 430 is clipped onto the left subclavian artery upstream of the reflux end 433, to ligate the artery.
• the lasso is wrapped over the left subclavian artery upstream of the reflux end 433.
• the clip 430 or the lasso can be adapted to ligate between 85% and 100% an artery under left keyboard.
• the clip 430 or the lasso is in this case linked to the reinjection cannula 43 thus making it possible to improve the surgical operation.
• the reinjection cannula 43 and the suction cannula 41 each have an internal diameter of between 5mm and 10mm, for example 5mm for the suction cannula 41 and 8mm for the reinjection cannula 43.
• the cannulas 41, 43 are made of l occurrence of polyethylene terephthalate in textile form (PET) or polytetrafluoroethylene in microporous form (ePTFE) or in another biocompatible material
• the unloading blood pump 40 therefore makes it possible to suck blood into the left atrium 10A via the suction end 411 of the suction cannula 41 and to reject it into the subclavian artery 30A via the reflux end 433 of the reinjection cannula 43.
• the unloading blood pump 40 is configured to absorb a blood flow rate between 0.05 liters per minute and 0.5 liters per minute. This flow thus makes it possible to relieve the pressure in the left atrium and thus also the pulmonary capillary pressure.
• Figure 2 shows a block diagram of the unloading blood pump 40 connected to the outlet end 412 of the suction cannula 41 and to the inlet end 432 of the delivery cannula 43.
• the unloading blood pump 40 comprises a casing 400 adapted to be incorporated into a human body 6 in which is located a pumping chamber body 402 sealed in the form of a volute.
• the pumping chamber body 402 comprises, in this example, a volume of 4 to 10 milliliters and is open to the inlet 401 having an internal diameter in this example greater than the outlet end 412 of the suction cannula 41, for example a diameter of 1 mm more than that of the outlet end 412 is in this example 6 mm.
• the body of the pumping chamber 402 is also open on one end of the volute shape on the outlet orifice 403 having an internal diameter, in this example, greater by 1 mm than that of the reinjection cannula 43 either here 9mm.
• the pumping chamber body 402 is in this case made of biocompatible titanium.
• the unloading blood pump 40 includes a turbine wheel housed in the pumping chamber body 402.
• the unloading blood pump 40 comprises an electric motor forming the driving part of the unloading blood pump 40.
• the unloading blood pump 40 is an electric centrifugal pump.
• the turbine wheel is also the rotor of the electric motor having an axis of rotation X.
• the turbine wheel is therefore in this example a turbine rotor 405 comprising a turbine body and permanent ferromagnetic magnets 405m housed in the body.
• the magnets can for example be made of neodymium or of Alnico alloy or else of platinum cobalt alloy.
• the turbine rotor 405 comprises for example a layer of polymer (Parylene and silicone), for example an overmolding in polymer on the magnets.
• the layer can also be biocompatible treated with chromium nitride and/or titanium nitride.
• the turbine wheel 405 can thus comprise, for example, four magnets distributed angularly in four housings of the body around the axis of rotation X, and are positioned with their polarities alternating angularly.
• the impeller rotor comprises notches each located between two magnets, each notch extending longitudinally emerging from the inlet orifice 412 at an outer periphery of the rotor turbine.
• the notch may comprise an inclined ramp increasing the axial depth of the notch from the inlet port to the outer periphery of the rotor, and in that each notch is open to the volume of the pumping chamber surrounding at least the notches of the rotor turbine. Arrows in the figure thus represent the circulation of blood in the turbine rotor.
• the body of the rotor turbine 405 has, in this example, an external diameter between 15 and 30 millimeters with an axial length also called axial height between 5 and 20 millimeters and the casing 400 in this example has a size of approximately 40x30mm to accommodate the electric motor stator(s) in addition to the pumping chamber body. Due to the low flow rate, the unloading blood pump 40 is thus much smaller than a prior art assistance pump and notably comprises a diameter of between 30mm and 50mm and an axial length of between 15mm and 40mm, for example in this example: 40mm in diameter and 30mm in axial length.
• the turbine body is made of biocompatible titanium, for example titanium nitrite or even ceramic material.
• such a pumping chamber body 402 with such a rotor turbine 405 can allow the pump to deliver between 0.05L/min and 0.5L/min of blood by rotating at a rotational speed between 2000 and 5000 revolutions per minute.
• the unloading blood pump electric motor 40 includes one or more stators housed in the housing, at least one of which is a wound stator 47 including winding coils 470 that produce a magnetic field when electrically energized to produce torque with turbine rotor 405. Either stator may include permanent magnets.
• the unloading blood pump 40 further includes a power supply connector 471 electrically connected to the winding coils 470 and the system further includes a power cable 7 connected to the pump connector 471 and a controller and power supply 8.
• the connector 471 can comprise an electrical connector made of a conductive material such as platinum or of copper and is coated with an insulator such as PolyEtherEtherKeton (PEEK) or Polysulfone (PSU) or a medical grade epoxy.
• control and supply device 8 is extracorporeal.
• the power cable 7 is therefore configured to cross the skin of a human body 6, in particular here, to pass in an inter-costal space or through the abdominal wall or retro-auricular.
• the power cable 7 can also be made of platinum and be covered with a medical insulator such as that of the cannulas or the connector 471.
• the control and supply device 8 comprises a control unit 80 for controlling the power transmitted to the pump motor and therefore its rotational speed and the flow rate of the blood pump.
• the control and supply device 8 further comprises a battery 81 electrically supplying the winding coils 470 of the stator 47 of the blood pump 40.
• the electric motor comprises two stators, a first lower stator 48 surrounding the inlet orifice comprising magnets 480, for example four in number regularly distributed around the axis of rotation and the other Upper coiled stator 47 axially opposite lower stator with respect to turbine rotor 405.
• Coiled stator 47 is axially closer than lower stator 48 thereby exerting greater axial force.
• Both stators include a diameter of 15mm with a height of 8mm.
• the unloading blood pump 40 is an electric centrifugal levitating pump comprising a passive permanent magnet bearing 46.
• the levitating bearing 46 comprises a shaft extending from the upper stator 47 axially in the pumping chamber body 402 and comprises a plurality of internal permanent magnets 460 integral with the axis, for example 3 magnets, stacked axially with their two poles repeated identically NS/NS/NS.
• the levitation bearing further comprises a plurality of hollow cylindrical outer permanent magnets 461 mounted on the rotor turbine body 405 and stacked axially with their two identically repeated poles NS/NS/NS surrounding the inner permanent magnets 460.
• a blood pump can be adapted to have a flow rate between 0.051/min and 0.31/min and therefore be even smaller, for example comprising a casing with a diameter of 3cm and with an axial length of 1.5cm and a body of the rotor turbine with a diameter of 15 millimeters and an axial length of 5 millimeters.
• the continuous flow of the pump is regulated according to the characteristics of the heart and the depression to be carried out.
• Figure 3 shows a second use of another example of a 4′ unloading blood pump system according to the first embodiment.
• This unloading blood pump system 4' is identical to the first example except that the suction cannula 41 and the delivery cannula 43 are made of a single material and surround the pump housing 40 and in that the control and supply device 8' is adapted to be incorporeal and comprises an induction charger 82 for charging the battery 81.
• This control and supply device 8' can be positioned in another space of the body such as for example in the chest wall, under a pectoralis major muscle or under a latissimus dorsi muscle.
• the second use is identical to the first use except in that the suction cannula 41 crosses the left ventricle 11A and therefore includes its suction end 411 in this left ventricle to suck blood and push it back into the artery under left clavicle 30A.
• the method of implantation of the unloading blood pump system 4 comprises in the first use two embodiments.
• the method comprises a first step of clamping the left atrium 10A and then a step of anastomosis of the suction end 411 of the suction cannula 41 on the left atrium 10A then a clamping removal step, from the left atrium.
• the method comprises a first step of inserting the suction end 411 of the suction cannula 41 into the left atrium 10A, endovascularly through initially the internal jugular vein then the right atrium then crossing the inter atrial septum for insertion of the end of the suction cannula 411 into the left atrium 10A.
• step of anastomosis of a cannula in a part of the heart is meant the insertion of the end of the cannula in the part of the heart for the connection of this cannula with the volume of this part of the heart.
• the method of implantation of the unloading blood pump system 4 comprises in the second use a step of placing the left ventricle under ventricular fibrillation then a step of anastomosis of the suction end 411 of the cannula d suction 41 directly into the left ventricle 11 A .
• the ventricular fibrillation stage may include a sub-stage of placement of points and a collar on the left ventricle with the heart beating before the contractions stop.
• the method then comprises in both uses, a step of debubbling the discharge pump.
• the method then comprises in both uses, a ligation step, for example by clipping the clip 430, of the subclavian artery 30A to ligate between 85 and 100% of the artery according to the calculated flow rate.
• a ligation step for example by clipping the clip 430, of the subclavian artery 30A to ligate between 85 and 100% of the artery according to the calculated flow rate.
• the method then comprises a clamping step in two zones of the subclavian artery 30A,
• the method then comprises a step of anastomosing the reinjection cannula 43 by inserting its reflux end 433 between the two clampings and downstream of the clipping 430,

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• 2020
  • 2020-07-16 FR FR2007445A patent/FR3112579B1/fr active Active
• 2021
  • 2021-07-15 CA CA3189345A patent/CA3189345A1/fr active Pending
  • 2021-07-15 WO PCT/EP2021/069750 patent/WO2022013349A1/fr unknown
  • 2021-07-15 JP JP2023502648A patent/JP2023533594A/ja active Pending
  • 2021-07-15 US US18/005,473 patent/US20230270993A1/en active Pending
  • 2021-07-15 EP EP21745774.6A patent/EP4182004A1/fr active Pending

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